The CIOMS March 2019 Newsletter is now available, click here.

ISPE Manuscript Project

The ISPE Strategic Planning Committee approved recently the following proposals submitted under the ISPE Manuscript Project. More than 20 proposals have been funded since the project’s inception in 2014.

• Propensity Scores in Real World Evidence. Work Group Co-Chairs: Til Sturmer & Robert Glynn
• Guidelines for Best Practices in Validation Studies in Pharmacoepidemiologic Studies that Use Routinely Collected Data. Chair: Work Group Chair: Vera Ehrenstein
• Guidance for the Application of Longitudinal Methods for Exposure Profiling in Pharmacoepidemiologic Studies in Pregnancy. Working Group Chair: Marleen van Gelder
• Developing a Framework for Combining Randomized Controlled Trial and Non-Randomized Data in Evidence Synthesis for Informed Health Care Decision Making. Work Group Chair: Grammati Sarri
• Observational External Comparator Cohorts as Controls for Long-Term Uncontrolled Extensions to Randomized Clinical Trial. Working Group Chair: Nancy Santanello

The 2019 Call for Manuscripts will be posted in late Spring.

Oncology Center of Excellence 2018 Annual Report

ISPE would like to inform you that the Oncology Center of Excellence 2018 Annual Report has been posted online. The report is highlighted on the OCE home page at www.fda.gov/OCE under “Spotlight” and can be accessed from the Annual Report webpage

Call for ISPE Representative to CIOMS:  Deadline: May 9

ISPE is an organisational member of CIOMS. There is a need for an ISPE member to liaise between the Society and CIOMS. Formal duties include attending the General Assembly, which takes place every two years in Geneva, attending any ad hoc meetings as required, and ensuring that both ISPE and CIOMS are informed of the activities of the other. Experience of being a member of an expert working group of CIOMS would be an advantage.

For more information click here

If you are interested in being considered to serve as ISPE’s representative to CIOMS, please send your CV to Mark Epstein (mepstein@paimgmt.com) by May 9.

Upcoming Webinars:

Comparing real world data with randomized trial results to assess validity
Tuesday, April 23, 2019
10:00am - 11:00am ET
Register for this webinar

Interested in presenting a webinar? Submit a webinar proposal here

EMA Upcoming Events

4.15.2019 - Deadline to submit comments
EMA Consultation: Role of big data for evaluation and supervision of medicines in the EU - Deadline for comments
4.30.2019 - Geneva
EMA Communication: CIOMS Open Meeting on Patient Involvement in Development and Safe Use of Medicines